This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase clostridium histolyticum \[CCH\]-aaes) treatment of cellulite in the buttocks.
CCH-aaes is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. Since bruising may be bothersome, this study will investigate treatments that may mitigate bruising after treatment of cellulite in the buttocks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
Participants were administered CCH-aaes by subcutaneous injection to both buttocks.
Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.
Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.
Endo Clinical Trial Site #3
Scottsdale, Arizona, United States
Endo Clinical Trial Site #2
Sacramento, California, United States
Endo Clinical Trial Site #7
San Diego, California, United States
Endo Clinical Trial Site #6
Fort Collins, Colorado, United States
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 4
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-point photonumeric scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 4 (3 days after CCH-aaes injection)
Number of Participants for Whom The Investigator Reported an Improvement of Bruising on the Mitigation-treated Buttock as Measured on the Investigator-Bruising Improvement Scores (I-BIS)
The investigator assessed improvement of bruising using the I-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). I-BIS Rating was directly obtained from the investigator's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock.
Time frame: Days 4 and 7
Number of Participants With an Improvement of Bruising on the Mitigation Treated Buttock on the Subject-Bruising Improvement Scale (S-BIS)
The investigator assessed improvement of bruising using the S-BIS, a 3-point Likert scale that compares bruising on the mitigated side to the bruising on the non-mitigated side as either worse (1), the same (2), or improved (3). S-BIS Rating was directly obtained from the participant's assessment rating comparing the bruising of the mitigation-treated buttock to the untreated (with mitigation treatment) buttock. The S-BIS assessment was not completed for participants that did not receive mitigation treatment (Cohort 1) or participants that received bilateral mitigation treatment (Cohort 2), as these participants did not have an untreated buttock as a comparator.
Time frame: Days 4 and 7
Number of Participants Bothered by the Appearance of Bruising as Assessed by the Patient Bother by Bruising Scale at Day 4
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Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.
Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.
Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.
Endo Clinical Trial Site #5
Chicago, Illinois, United States
Endo Clinical Trial Site #1
Shreveport, Louisiana, United States
Endo Clinical Trial Site #8
Boston, Massachusetts, United States
Endo Clinical Trial Site #4
Nashville, Tennessee, United States
The Patient Bother by Bruising Scale is a 4-point scale, with a score of 1 indicating not bothered at all, and a score of 4, indicating extremely bothered. A lower score indicates a better outcome.
Time frame: Day 4
Number of Participants With an Improved (+1 or Better) Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) at Day 71
Improvement was defined as +1 or better score on the I-GAIS for either buttock on Day 71 compared to Baseline. The I-GAIS is a 7-level scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome.
Time frame: Day 71
Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 7
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 7
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 14
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 14
The Number of Participants by Buttock at Each Level of Bruising on the Investigator Assessment of Bruising Severity Scale at Day 22
Participants were assessed by the investigator using the Investigator Assessment of Bruising Severity Scale. The Investigator Assessment of Bruising Severity Scale is a 5-level scale ranging from 0 to 4, with "0" indicating no bruising or almost none, and "4" indicating very severe bruising. Higher scores indicated worse outcome.
Time frame: Day 22